MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending to right distal superficial femoral artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 100 mm and 100% stenosis.It was classified as a tasc ii 64b lesion.Prior to target lesion treatment, a 5 mm x 190 mm non-boston scientific embolization protection device was used, and pre-dilatation was performed with a 6 mm x 100 mm non-boston scientific pta balloon.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon of 5.0 mm x 120 mm.On the same day of index procedure, during treatment of the target lesion, a grade c dissection was noted.In response to the event, a bailout stent was implanted, and the complication was resolved.On (b)(6) 2021, the subject was discharged from the hospital.
Additional Manufacturer Narrative
Patient information: patient id: (b)(6).Age at time of event: (b)(6) at the time of study enrollment.
Additional Manufacturer Narrative
Patient information: patient id: (b)(6).Age at time of event: (b)(6) at the time of study enrollment.
Event or Problem Description
It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending to right distal superficial femoral artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 100 mm and 100% stenosis.It was classified as a tasc ii 64b lesion.Prior to target lesion treatment, a 5 mm x 190 mm non-boston scientific embolization protection device was used, and pre-dilatation was performed with a 6 mm x 100 mm non-boston scientific pta balloon.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon of 5.0 mm x 120 mm.On the same day of index procedure, during treatment of the target lesion, a grade c dissection was noted.In response to the event, a bailout stent was implanted, and the complication was resolved.On (b)(6) 2021, the subject was discharged from the hospital.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13502165
• Report Number: 2134265-2022-01407
• Device Sequence Number: 5247686
• Product Code: ONU
• UDI-Device Identifier: 08714729976004
• UDI-Public: 08714729976004
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027517970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White